Kiran Mazumdar-Shaw, Biocon executive chair (Samyukta Lakshmi/Bloomberg via Getty Images)

Biosim­i­lars unite: Look­ing for com­mer­cial con­sol­i­da­tion, Bio­con buys out long­time part­ner Vi­a­tris for $3.3B

Turn­ing a years-long part­ner­ship in­to own­er­ship, Bio­con is shelling out $3.335 bil­lion to buy out Vi­a­tris’ biosim­i­lars busi­ness.

Re­ports first emerged weeks ago about plans to merge the two com­pa­nies’ biosim­i­lars unit in­to a $10 bil­lion stand­alone busi­ness. The bi­o­log­ics group un­der Bio­con, a dom­i­nant gener­ics play­er out of In­dia, had been work­ing with My­lan on de­vel­op­ing biosim­i­lars for the world long be­fore My­lan merged with Pfiz­er’s Up­john to be­come Vi­a­tris. To­geth­er, they boast of many firsts — in­clud­ing launch­ing the first in­ter­change­able biosim­i­lar in the US, for the in­sulin Lan­tus.

“The deal will en­able (Bio­con Bi­o­log­ics) to at­tain a ro­bust com­mer­cial en­gine in the de­vel­oped mar­kets of U.S. & Eu­rope and will fast-track our jour­ney of build­ing a strong glob­al brand,” said Ki­ran Mazum­dar-Shaw, the ex­ec­u­tive chair­per­son of Bio­con Bi­o­log­ics. “It will al­so make us fu­ture-ready for the next wave of prod­ucts.”

Talk­ing to In­di­an press, Mazum­dar-Shaw said she en­vi­sions an IPO for Bio­con Bi­o­log­ics in two years.

Bio­con Bi­o­log­ics es­ti­mates that the buy­out would give it an im­me­di­ate ad­di­tion­al $1 bil­lion in cash next year ($875 mil­lion in rev­enue plus $200 mil­lion in EBIT­DA), along with com­mer­cial in­fra­struc­ture around the world and a port­fo­lio of in-li­censed biosim­i­lar as­sets.

The deal con­sists of $2.335 bil­lion in cash plus “com­pul­so­ri­ly con­vert­ible pref­er­ence shares” in Bio­con Bi­o­log­ics val­ued at $1 bil­lion.

Hav­ing se­cured about $800 mil­lion through eq­ui­ty in­fu­sion, Bio­con not­ed it will fund the rest of the ac­qui­si­tion by a mix of debt and ad­di­tion­al eq­ui­ty.

Arun Chan­davarkar

For the next two years, Vi­a­tris will keep pro­vid­ing com­mer­cial and oth­er tran­si­tion ser­vices be­fore turn­ing things over ful­ly to Bio­con. Ra­jiv Ma­lik, pres­i­dent of Vi­a­tris, will al­so jump on Bio­con Bi­o­log­ics’ board.

The “strate­gic agili­ty and op­er­a­tional ef­fi­cien­cies” al­lowed by a com­bi­na­tion will help “mit­i­gate pric­ing pres­sures in a com­pet­i­tive glob­al biosim­i­lars land­scape,” added Arun Chan­davarkar, man­ag­ing di­rec­tor, Bio­con Bi­o­log­ics.

Where­as Bio­con and Vi­a­tris have made some head­way in­to the Eu­ro­pean mar­ket, find­ing foot­ing in the US mar­ket has proven chal­leng­ing. In a bizarre twist, even af­ter they land­ed the much-cov­et­ed in­ter­change­able sta­tus for their Lan­tus biosim­i­lar, the com­pa­nies had to launch two ver­sions of the in­ter­change­able — one at a 65% dis­count, and one at a much high­er price in or­der to gain mar­ket share.

Their port­fo­lio of biosim­i­lars and in­sulin analogs in­clude copy­cat ver­sions of Hu­mi­ra, Her­ceptin, Neu­las­ta, and En­brel.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.

Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

Hori­zon Ther­a­peu­tics in takeover talks with Am­gen, J&J, Sanofi as po­ten­tial buy­ers

Amgen, J&J’s Janssen and Sanofi are all in talks to acquire Horizon Therapeutics, the rare disease biotech disclosed late Tuesday.

Horizon confirmed “highly preliminary discussions” with those companies regarding a potential buyout offer after the Wall Street Journal reported takeover interest.

Although the company — which commands a market cap of close to $18 billion — emphasized that “there can be no certainty that any offer will be made for the Company,” shares $HZNP still surged 31% in after-hours trading to near $103, bringing it to the point where it started the year.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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